Clip applier (with detachable titanium clip cassette)

1

2

1 13

D

E 5

2

3

10

G

F 5

14 9

4

11

8

1

4

7

I

H 14

A

11

1

2

J

B

12

6 14

14

C

L

K

11

en

2.2.2

Aesculap Clip applier (with detachable titanium clip cassette)

Note Ligating clips are intended for use on vessels and tissue structures (e.g. the biliary tract) for which the surgeon believes ligating clips are the best tools. The size, type and material of the clip are selected by the surgeon, based on his experience, estimation and requirement.

Legend 1 Shaft 2 Swivel ring 3 Screw handle 4 Application lever (for closing the clip) 5 Loading lever 6 Pushing rod 7 Inner tube 8 Space for titanium clip cassette 9 Star wheel 10 Retaining ring 11 Jaws protector 12 Stop 13 Cassette feeder 14 Lubrication points

1.

2.2.3

2.2.4

Relative contraindications

The following conditions, individual or combined, may result in delayed healing or compromised surgical success: ■ Medical or surgical conditions that could prevent the success of the operation, e.g. connective tissue disorders (e.g. Marfan syndrome) or infections. In the case of relative contraindications, the user decides individually on the use of the product.

2.3

Scope

These instructions for use apply for the following products: Art. no.

Designation

PL510R

HANDLE ALL.ZU PL506R U.PL508R

PL602R

HANDLE ALL.ZU PL600R

PL506R

APPLICATION FORCEPS 10/370MM MAGAZINIERB.

PL508R

APPLICATION FORCEPS 10/260MM MAGAZINIERB.

PL512R

CLIP APPLICATOR D:5/310MM F.PL572T

PL600R

CLIP APPLICATOR D:5/205MM F.PL572T

PL536R

SHAFT COMPL.D:10MM L:370MM

PL538R

SHAFT COMPL.D:10MM L:260MM

PL522R

SHAFT COMPL.D:5MM L:310MM

PL601R

SHAFT ALL.205MM ZU PL600R

Risks, adverse effects and interactions

The following possible undesired effects or interactions currently know to the manufacturer are referenced within the framework of the legal information reporting requirement. These are procedural, not product-specific and include infection, migration/dislocation of the clip with the possibility of (re)opening of a closed cavity organ/vessel (such as bleeding), necrosis of the clipped structure, injury to the treated or neighboring tissue structures and sensitivity to the metal components of the clip.

About this document

2.4

Safety information

2.4.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.4.2

Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at

eifu.bbraun.com

1.2

Absolute contraindications

Do not use: ■ on the central nervous system ■ in case of foreign-body sensitivity for titanium ■ in contraceptive procedures such as tubal litigation, vasectomy

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Indications

■ Ligation of vessels and hollow organs ■ Marking of anatomic structures for radiological detection

®

Product-specific safety information

Note The applicability of ligating clips (in the respectively available clip size) depends on the size of the structure and is at the discretion of the user. Use is also effected in the context of the vessel condition and/or whether clip application is generally indicated. The position of the clip must be checked by the user after application. ► To avoid damage to the jaws and the titanium clip cassette: carefully insert the product through the trocar. ► In order to prevent unintentional releasing of the shaft from the handle by retracting the star wheel: push the

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows:

securing ring 10 onto the handle to the star wheel from the rear and rotate by 180°. ► Keep the jaw protector installed when the clip applier is not in use. ► Only use the product with visual control.

WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

2.4.3

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

The product is delivered in an unsterile condition. ► Check the new product for damage after removing its transport packaging and clean prior to its initial sterilization.

2. 2.1

2.5

Clinical use Art. no./Dimensions

Clip applier (with insertable titanium clip cassette), complete

PL506R

PL508R

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product.

Available sizes

Length

Sterility

PL512R

PL600R

WARNING Risk of injury to the patient and/or damage to the instrument if incompatible trocars are used! ► When using the instrument with a trocar: – Check the compatibility of the trocar and instrument (with titanium clip cassette). – Guide instrument into or out of the trocar only with opened jaws.

Shaft diameter

10 mm

10 mm

5 mm

5 mm

Length

370 mm

260 mm

310 mm

205 mm

Handle only

PL510R

PL510R

PL510R

PL602R

Shaft only (including interior tube and pushing rod)

PL536R

PL538R

PL522R

PL601R

Pushing rod only

PL536801

PL538801

PL522800

PL601800

Inner tube only

PL536802

PL538802

PL522801

PL601801

► Insert the clip applier carefully, in a straight line and centrally through the trocar.

Jaws protector

PL536810

PL536810

PL522810

PL522810

2.5.1

Retaining ring

PL510301

PL510301

PL510301

PL510301

Demounting the jaws protector ► Compress the jaw part protection 11 and carefully remove it in the direction of the shaft, see Fig. J.

Star wheel

PL510300

PL510300

PL510300

PL510300

Titanium clip cassette, size: small-medium (12 cassettes, each of 12 clips)

-

-

PL572T

PL572T

Titanium clip cassette, size: medium-large (12 cassettes, each of 8 clips)

PL569T

PL569T

-

-

2.2

Areas of use and limitations of use

2.2.1

Intended use

The clip applier (with insertable titanium clip cassette) is used for the ligation of vessels and hollow organs and for marking anatomical structures. The product is used in combination with Aesculap titanium clip cassettes.

WARNING Risk of dislocation of clips by cutting tissue too close to clip! ► When cutting clipped structures, leave an area of tissue of at least the width of double the clip between the clip and cutting site. ► Ensure that the structure is not under tension when cutting.

Setting up the clip applier

Assembling the clip applier ► Assembling the clip applier, see Chapter 3.12. Function check ► Push application lever 4 of the clip applier through to the limit stop and release it again, see Fig. H. Application lever 4 moves back to its rest position. ► Push loading lever 5 down to the stop and release it again, see Fig. G. The pushing rod 6 must be moved forwards and backwards in the shaft 1. The movement is visible at the position for the titanium clip cassette 8. The loading lever 5 moves back to its rest position. Note In order to be able to perform a loading process again, the application lever 4 must be actuated after the loading lever 5 has been actuated.

Inserting the titanium clip cassette ► Push application lever 4 of the clip applier through to the limit stop and release it again, see Fig. H. Application lever 4 moves back to its rest position. ► Insert the titanium clip cassette into the shaft 1 using the magazine feeder 13. When doing this, make certain the feeder is not damaged in the process; see Fig. E. ► Push down the titanium clip cassette until the lugs at its sides engage in the clip applier, see Fig. F. The clip applier is ready for use.

3.6.2

2.5.2

3.6.3

Operating the clip applier

Note The last clip in each titanium clip cassette is color-marked in order to indicate that the titanium clip cassette will be empty after the present application! Note Do not close the jaws of the instrument when inserting/approaching the structure to be clipped. ► Load clip: Push loading lever 5 to the stop and release it again, see Fig. G.

The loading lever 5 moves back to its rest position. Note In case of any malfunction at this stage, clip loading must be inspected and repeated extracorporeally. CAUTION Clip applier malfunction due to interrupted loading process! ► Complete the loading process and do not interrupt it under any circumstances, as otherwise there may be a clip jam. ► In the event of a clip jam, end the loading process immediately and replace the cassette. ► Close clip: Push application lever 4 of the clip applier through to the limit stop, see Fig. H.

Disassemble the clip applier

► With safety ring 10 mounted: rotate the safety ring 10 until the opening of the ring points downward in the

direction of the application lever 4 and loading lever 5. ► Hold the shaft 1, pull the rotary ring 2 to the stop in the direction of the handle 3 and remove the shaft 1,

see Fig. C. ► Pull off safety ring 10 towards rear of handle. ► Remove the rotary star 9 from the rotary ring 2.

Disassembling the shaft

► Withdraw inner tube 7 from shaft 1. ► Pull the pushing rod 6 from the inner tube 7.

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the reprocessing method

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents, – that are approved for peek plastics and stainless steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Compress jaws protector 11 and cautiously guide it over the jaws to the stop 12 at the outer tube, see Fig. K. ► If the product can be fixated on storage devices safely and appropriately for cleaning: carry out mechanical

cleaning and disinfecting.

3.7.2

Validated cleaning and disinfection procedure

► Close the clip only in the clip guide in the jaws of the clip applier. Make sure the clip is applied under visual

Validated procedure

Specific requirements

Reference

control. ► Check the fit and operability of the clip. ► If necessary apply another clip. ► Dispose of titanium clip magazine after the operation.

Manual cleaning with ultrasound and immersion disinfection

Chapter Manual cleaning/disinfection and subsection:

2.5.3

■ Shaft

■ Suitable cleaning brush: e.g. PM995R or GK469R ■ Single use syringe 20 ml ■ Place the jaw part protection 11 onto the product. ■ Drying phase: Use a lint-free cloth or medical com-

Changing the titanium clip cassette

► Remove the empty titanium clip cassette, see Chapter 3.6.1. ► Carry out function check, see Chapter 2.5.1. ► Insert new titanium clip cassette, see Chapter 2.5.1.

3.

Validated reprocessing procedure

3.1

General safety information

■ Screw handle

Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

ing with ultrasound and immersion disinfection

pressed air Mechanical alkaline cleaning and thermal disinfection

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

■ Chapter Manual clean-

■ Place the product on a tray that is suitable for clean-

Chapter Mechanical cleaning/disinfection and subsection:

ing (avoid rinsing blind spots).

■ Chapter Mechanical alkaline cleaning and thermal disinfection

Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ Suitable cleaning brush: e.g. PM995R or GK469R ■ Single use syringe 20 ml ■ Place the jaw part protection 11 onto the product. ■ Place the product on a tray that is suitable for clean-

■ Shaft

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■ Chapter Manual precleaning with ultrasound and brush

ing (avoid rinsing blind spots).

■ Chapter Mechanical

Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. Evidence of biocompatibility and processibility for the product was produced by the manufacturer after 50 processing cycles. A careful visual and functional inspection before the next use is the best option to determine if a product is no longer functional, see Chapter 3.11. The recommended annual servicing reduces the risk of failure and extends the service life of the product; see Chapter 4.1.

3.4

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.5

Preparing for cleaning

► Fixation screws which permanently connect the various components must not be disassembled. ► Disassemble the product prior to cleaning, see Chapter 3.6. ► Open up instruments with hinges.

3.6

Disassembly

3.6.1

Removing the titanium clip cassette

► Close the jaws with the application lever 4 and withdraw the titanium clip cassette; see figure B.

alkaline cleaning and thermal disinfecting

3.8

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

3.8.1

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Chapter 3.7.2.

Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.

Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Chapter 3.7.2.

3.11.1 Visual inspection

3.9

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps.

Mechanical cleaning/disinfection

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.9.1

3.11 Inspection

Mechanical alkaline cleaning and thermal disinfection

► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see

Machine type: single-chamber cleaning/disinfection device without ultrasound

Chapter 4.2.

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline

3.11.2 Functional test CAUTION Damage (metal cold welding /friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate the identified lubrication points 14 with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598), see Fig. I. ► Assemble disassembled products, see Chapter 3.12. ► Check that the product functions correctly.

– Close jaws from the tip to the rear. – The tips must contact when the jaws are closed. – the closed jaws may not intersect. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Chapter 4.2.

3.12 Assembly CAUTION Malfunctions caused by incorrect assembly sequence! ► Keep to the correct order of assembly.

3.12.1 Assembling the shaft

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

► Push the pushing rod 6 into the inner tube 7. ► Push the inner tube 7 into the shaft 1 using the pushing rod 6.

3.10 Mechanical cleaning/disinfection with manual pre-cleaning

3.12.2 Assembling the clip applier

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).

► Push the star wheel 9 onto the rotary ring 2. ► Pull the rotary ring 2 to the stop in the direction of the handle 3. ► Hold the rotary ring 2 on the stop and push in the assembled shaft 1. Press the shaft 1 against the handle 3 and

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

turn it until the marking lines are in line with the shaft 1 and rotary ring 2 and the rotary ring 2 snaps forward, see Fig. D. ► Push the securing ring 10 onto the handle 3 to the rotary ring 2 from the rear and rotate by 180°.

3.10.1 Manual pre-cleaning with ultrasound and brush

3.13 Packaging

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Rinsing

RT (cold)

1

-

D–W

-

► Place the product in its holder or on a suitable tray. Make certain the jaws are protected. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.14 Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by

opening any valves and faucets). ► Validated sterilization process

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Chapter 3.7.2.

Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

3.10.2 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH ~ 13 – <5 % anionic surfactant

■ working solution 0.5% – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

3.15 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

4.

Maintenance and Service

4.1

Maintenance

To ensure reliable operation, Aesculap recommends maintaining the product as indicated on the maintenance label, see Fig. L. ► For corresponding services, contact your national B. Braun/Aesculap agency. see Chapter 4.2

4.2

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

-

4.3

Accessories/Replacement Parts

IV

Thermal disinfecting

90/194

5

FD-W

-

Accessories and spare parts are listed in the Endoscopy online catalog at www.endoscopy-catalog.com or in the Aesculap brochure C46111.

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

5.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging.

6.

Symbols on product and packaging Maintenance labeling on the handle and shaft with a note regarding the next maintenance deadline, see Chapter 4.1

YYYY-MM TA010094

2020-10

V6

Change No. 63345